Process for the continuous preparation of sterile, depyrogenated solutions

Abstract

A process for sterilizing and depyrogenating a pretreated solution, such as water, by adding an oxidant selected from the group consisting of hydrogen peroxide and ozone and heating the solution and the oxidant to a temperature sufficient to sterilize and depyrogenate the solution for a period of time, preferably less than 5 minutes. The oxidant is thereafter removed and the sterilized, depyrogenated solution is cooled for dispensing.

What is claimed is: 
     
       1. A sterilizing and depyrogenating process comprising the steps of: treating a stream of a solution to remove contaminants therefrom;   adding a discrete amount of an oxidant selected from the group consisting of hydrogen peroxide and ozone to said stream of treated solution;   heating said stream of such treated solution and said oxidant to a temperature in the range of about 212° F. to 300° F. and for a period of time less than about ten minutes sufficient to simultaneously sterilize and depyrogenate such treated solution while said solution is being heated, said amount of oxidant added to said stream of solution being effective, when said stream of solution and said oxidant are heated to said temperature, to depyrogenate said solution; and   removing any residual of said oxidant from said stream of such treated, sterilized, depyrogenated solution.   
     
     
       2. A process as recited in claim 1 wherein said solution is a parenteral solution. 
     
     
       3. A process as recited in claim 1 wherein said amount of said oxidant is about 100 mg of hydrogen peroxide per liter of said solution. 
     
     
       4. A process as recited in claim 1 wherein said oxidant is about 8% ozone by weight bubbled into said stream of such treated solution. 
     
     
       5. A process as recited in claim 4 wherein said amount is about 10 mg of ozone per liter of said solution. 
     
     
       6. A process as recited in claim 1 wherein said heating step comprises passing said stream of such treated solution and said oxidant through a heat exchanger. 
     
     
       7. A process as recited in claim 1 wherein said removing step includes catalytically destroying said oxidant. 
     
     
       8. A process as recited in claim 1 wherein said temperature is in the range of about 250° F. to 270° F. 
     
     
       9. A process as recited in claim 1 wherein said period of time is less than about 5 minutes. 
     
     
       10. A process for the sterilization and depyrogenation of pretreated water comprising the steps of: bubbling a discrete amount of ozone into a stream of said water and heating said stream of water and said ozone to a temperature within the range of about 250° F. to 270° F. for a period of time less than about ten minutes sufficient to simultaneously sterilize and depyrogenate said water while said water is being heated, said amount of ozone bubbled into said stream of water being effective, when said stream of water and said ozone are heated to said temperature, to depyrogenate said water.   
     
     
       11. A process as recited in claim 10 wherein said amount of ozone is about 10 mg of ozone per liter in said water. 
     
     
       12. A process as recited in claim 10 wherein said period of time is less than 5 minutes. 
     
     
       13. A process as recited in claim 10 wherein said period of time is about 3 to 5 minutes. 
     
     
       14. A process as recited in claim 10 wherein said heating step includes passing said stream of water and ozone through a heat exchanger.